Associate Principal Scientist, Preclinical Development

Role: Associate Principal Scientist supporting biologics sterile product development within the Sterile Product Development (SPD) group. Objectives: lead innovative biologics formulation and process development, support early and late-stage candidates, and contribute to regulatory filings. Responsibilities: design and execute experiments for biologics drug products, oversee process scalability, primary packaging, and compatibility; lead technology transfers and external manufacturing collaborations; provide strategic and technical leadership on programs; mentor scientists and drive innovation aligned with organizational goals. Qualifications: Ph.D. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, or related field with at least 3 years (Ph.D.) or 8 years (B.S./M.S.) of industry experience in biologics process development. Skills: expertise in biologics formulation, characterization, process development, and regulatory submission; strong communication and leadership abilities. Preferred: experience leading enterprise-level projects, mentoring, subject matter expertise in drug delivery or manufacturing tech, and process scale-up knowledge. High-Value: biologics, sterile injectable drug products, late-stage development, process characterization, regulatory filings, external manufacturing, and innovation in drug delivery technologies. Work setup: not specified; travel approximately 10%.